Long-term results of a multicenter SAKK trial on high-dose ifosfamide and doxorubicin in advanced or metastatic gynecologic sarcomas.

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Serval ID
serval:BIB_CE5C6C250345
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Long-term results of a multicenter SAKK trial on high-dose ifosfamide and doxorubicin in advanced or metastatic gynecologic sarcomas.
Journal
Annals of Oncology
Author(s)
Leyvraz S., Zweifel M., Jundt G., Lissoni A., Cerny T., Sessa C., Fey M., Dietrich D., Honegger H.P. and 
ISSN
0923-7534
Publication state
Published
Issued date
2006
Peer-reviewed
Oui
Volume
17
Number
4
Pages
646-651
Language
english
Abstract
BACKGROUND: Dose intensive chemotherapy has not been tested prospectively for the treatment of gynecologic sarcomas. We investigated the antitumor activity and toxicity of high-dose ifosfamide and doxorubicin, in the context of a multidisciplinary strategy for the treatment of advanced and metastatic, not pretreated, gynecologic sarcomas. PATIENTS AND METHODS: Thirty-nine patients were enrolled onto a phase I-II multicenter trial of ifosfamide, 10 g/m2 as a continuous infusion over 5 days, plus doxorubicin intravenously, 25 mg/m2/day for 3 days with Mesna and granulocyte-colony-stimulating factor every 21 days. Salvage therapy was allowed after chemotherapy. RESULTS: Among the 37 evaluable patients, the tumor was locally advanced (n = 11), with concomitant distant metastases (n = 5) or with distant metastases only (n = 21). After a median of three (range 1-7) chemotherapy cycles, six patients experienced a complete response and 12 a partial response for an overall response rate of 49% (95% CI 32% to 66%). The response rate was higher in poorly differentiated tumors (62%) compared with moderately well differentiated ones (18%), but was not different according to histology subtypes. Eleven patients had salvage therapy, either immediately following chemotherapy (n = 7) or at time of progression (n = 4). With a median follow-up time of 5 years, the median overall survival was 30.5 months. Hematological toxicity was as expected neutropenia, thrombopenia and anemia > or = grade 3 at 50%, 34% and 33% of cycles respectively. No toxic death occurred. CONCLUSIONS: High-dose ifosfamide plus doxorubicin is an active regimen for all subtypes of gynecological sarcomas. Its toxicity was manageable in a multicentric setting. The prolonged survival might be due to the multidisciplinary strategy that was possible in one-third of the patients.
Keywords
Antineoplastic Combined Chemotherapy Protocols, Dose-Response Relationship, Drug, Doxorubicin, Female, Genital Neoplasms, Female, Humans, Ifosfamide, Neoplasm Metastasis, Sarcoma, Survival Analysis
Pubmed
Web of science
Open Access
Yes
Create date
28/01/2008 9:32
Last modification date
25/09/2019 7:10
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